NCT02784457

Brief Summary

Efficacy of the use of GnRH antagonist in treatment of those who develop early-onset severe ovarian hyperstimulation syndrome and had cancelled embryo transfer

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jun 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 23, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
Last Updated

May 27, 2016

Status Verified

May 1, 2016

Enrollment Period

1.5 years

First QC Date

May 23, 2016

Last Update Submit

May 24, 2016

Conditions

Assisted Reproduction

Outcome Measures

Primary Outcomes (1)

  • Number of women who needed culdocentesis or paracentesis of the ascitic fluid

    within 2 weeks of onset

Secondary Outcomes (3)

  • Number of women who needed hospitalization

    within 2 weeks of onset of symptoms

  • Time to regression of nausea/vomiting

    within 2 weeks of onset of symptoms

  • Time to regression of large ovarian size

    within 4 weeks of onset of symptoms

Study Arms (2)

GnRHant

ACTIVE COMPARATOR

women who received GnRH antagonist

Drug: Cetrorelix

Control

NO INTERVENTION

women who did not receive GnRH antagonist

Interventions

CetrorelixDRUG
GnRHant

Eligibility Criteria

Age20 Years - 42 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Women who develop early-onset severe ovarian hyperstimulation syndrome after controlled ovarian stimulation using long GnRH agonist protocol and hCG for triggering ovulation.

You may not qualify if:

  • Women on short or antagonist protocols.
  • Women who received GnRH agonist for triggering ovulation.
  • Women who had embryo transfer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

cetrorelix

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

May 23, 2016

First Posted

May 27, 2016

Study Start

June 1, 2014

Primary Completion

December 1, 2015

Study Completion

March 1, 2016

Last Updated

May 27, 2016

Record last verified: 2016-05